Giro Growth Modulation System Gro-DRC146
Giro Growth Modulation System Gro-DRC146 is a Class I device made by Orthopediatrics Canada ULC, cleared under FDA 510(k) K220190 on 24 Oct 2022 and listed in FDA GUDID since 29 Nov 2022 (UDI-DI 07540194013620), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07540194013620 | Date29 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220190 | Date24 Oct 2022 | StatusActive |
Official records
- AccessGUDID record 07540194013620
- FDA 510(k) database K220190
Across registries
- FDA 510(k) K220190 decided 24 Oct 2022 Active
- FDA GUDID UDI-DI 07540194013620 listed 29 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K220190
- Listed FDA GUDID 07540194013620
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Giro Growth Modulation System
- Generic name
- Cannulated surgical drill bit, reusable
- Model / Ref / Catalog
- GRO-DRC146
- Primary DI / UDI-DI
- 07540194013620
- 510(k) Number
- FDA product code
- HTW
- GMDN term
- Cannulated surgical drill bit, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Lumen/Inner Diameter — 2.2 MillimeterOuter Diameter — 4.6 Millimeter
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